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CN106798600A - 一种组合支架 - Google Patents

一种组合支架 Download PDF

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Publication number
CN106798600A
CN106798600A CN201710134410.9A CN201710134410A CN106798600A CN 106798600 A CN106798600 A CN 106798600A CN 201710134410 A CN201710134410 A CN 201710134410A CN 106798600 A CN106798600 A CN 106798600A
Authority
CN
China
Prior art keywords
connector
distal
proximal
bone
bone support
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201710134410.9A
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English (en)
Other versions
CN106798600B (zh
Inventor
李波
张国伟
徐保东
赵国栋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangxing Lihua Beijing Technology Co ltd
Original Assignee
Beijing Shape Dream Information Technology Co Ltd
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Publication of CN106798600A publication Critical patent/CN106798600A/zh
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Publication of CN106798600B publication Critical patent/CN106798600B/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/74—Devices for the head or neck or trochanter of the femur
    • A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及医疗器械领域。本发明提出一种组合支架，包括：骨头支撑件(1)，骨头支撑件(1)内具有孔道(12)；近端连接件(2)，近端连接件(2)连接骨头支撑件(1)尾部，近端连接件(2)内具有孔道(12)；和远端连接件(3)，远端连接件(3)连接在近端连接件(2)尾部，远端连接件(3)内具有孔道(12)，骨头支撑件(1)、近端连接件(2)和远端连接件(3)构成支架连接后，其内部的孔道(12)相互贯通。本发明的组合支架可实现血管的联合移植治疗股骨头缺血性坏死。

Description

一种组合支架
技术领域
本发明涉及医疗器械。更具体地，涉及一种医用组合支架。
背景技术
股骨头坏死又称股骨头缺血性坏死，是骨科领域的常见且难治性疾病。它是由于多种原因导致的股骨头局部血运不良，从而引起骨细胞进一步缺血、坏死、骨小梁断裂、股骨头塌陷的一种病变。若未经有效治疗，约80％的患者会在1-4年内发生股骨头塌陷，继发关节功能障碍，最终患者不得不接受人工关节置换术，人工关节置换的高额费用给患者及社会带来了巨大的经济负担，而且由于人工关节有一定的寿命，中青年患者的关节置换后往往还面临着关节松动的问题，人工关节翻修手术难度及风险较高，人工关节翻修也将进一步加重患者的经济负担并显著降低患者的生活质量。最新研究表明股骨头坏死的发病率近年来呈逐年升高的趋势，而且其发病年龄呈现年轻化趋势。因此早期治疗股骨头坏死，以保留患者自身关节的治疗方法一直备受关注。
早期清除病灶，使用植入材料填充支撑缺损区域并促进骨再生是目前研究和临床治疗的热点之一。既往的材料研究中采取了干细胞治疗、自体骨/人工骨材料填充治疗及钽棒植入治疗等，然而均未取得令人满意的治疗效果。因为股骨头坏死的重要病因是其病变区域内血供受损或中断，这些材料虽然具有生物力学支撑或促进成骨的性能，但是难以重建病变区域的微循环系统，因此无法为注射的干细胞或新生的骨组织提供必须的营养及清除代谢废物，从而无法得到理想的治疗效果。
因此早期股骨头坏死的有效治疗方法需要同时解决以下三个问题：病灶清除后骨缺损区域的生物力学支撑、局部微循环系统的重建以及促进骨组织的再生修复。
另外，既往针对股骨头坏死所使用的钽棒治疗，后期如果因为病情进展仍需进行人工关节置换术时，由于股骨颈截骨区有金属钽棒的存在而无法直接截骨，需先将钽棒取出；由于多孔钽棒有骨长入，因此无法通过螺钉旋转的方式直接拧出。
使用环钻钻孔以使支架与骨分离是可行的方式之一，但取出过程往往极为困难，环钻常常切割支架，造成大量金属磨屑，难以清理；而且容易造成支架断裂或局部的骨折(如大转子骨折等)，从而增加手术难度并导致关节置换后假体的稳定性下降，明显影响手术效果。
发明内容
根据现有技术中的问题，本发明提出一种组合支架，包括：骨头支撑件，骨头支撑件内具有孔道；近端连接件，近端连接件连接骨头支撑件尾部，近端连接件内具有孔道；和远端连接件，远端连接件连接在近端连接件尾部，远端连接件内具有孔道，骨头支撑件、近端连接件和远端连接件构成支架连接后，其内部的孔道相互贯通。
可选地，孔道的数量为至少两个，孔道在远端连接件的底部穿出，在骨头支撑件的顶部或侧部相互连通。
可选地，骨头支撑件的顶端或顶部的侧方具有凹陷以形成开窗，孔道在该凹陷中连通。
可选地，所述开窗配有用于遮盖所述开窗的盖。
可选地，孔道之间伴有中隔。
可选地，远端连接件的尾部的底端或侧面具有凹槽、凹孔或凸起结构。
可选地，近端连接件与骨头支撑件为一体化结构。
可选地，远端连接件的尾部外围具有螺纹区，凹槽、凹孔或凸起结构位于所述螺纹区内。
可选地，近端连接件具有用于连接的螺纹结构，远端连接件的近端具有用于连接的螺纹结构，近端连接件与远端连接件通过连接螺纹结构相互拧入而实现匹配组合。
可选地，骨头支撑件为多孔结构，近端连接件为实心的或小孔结构，远端连接件为实心的非多孔结构。
本发明的有益效果为：其能够联合血管移植治疗股骨头坏死，可修复病灶清除后局部的生物力学强度，重建局部的微循环系统，促进骨组织的再生修复。
而且，若后期出现股骨头坏死塌陷，需要行关节置换手术时，由于近端部分有骨长入，远端部分为实心结构没有骨长入，可将远端部分拧出，再于股骨颈部截断股骨颈，而截骨区不再有支架的干扰。
附图说明
图1为本发明的组合支架的一个实施例拆分后的示意图；
图2为图1中的组合支架组装后的透视图；
图3为本发明的支架顶部开窗的一个实施方式的立体图；
图4为本发明的支架顶部开窗的另一个实施方式的立体图；
图5为本发明的支架顶部开窗的又一个实施方式的立体图；
图6为本发明的支架尾部的一个实施方式的立体图；
图7为本发明的支架尾部的又一个实施方式的立体图；
图8为本发明的支架尾部的又一个实施方式的立体图；
图9为本发明的支架开窗顶盖的一个实施方式的立体图。
附图标记
1-骨头支撑件；12-孔道；13-螺纹区；14-凹槽；15-凹孔；
16-凸起结构；17-盖；18-外置的连接螺纹结构；19-内置的连接螺纹结构；
2-近端连接件；3-远端连接件。
具体实施方式
下面参照附图描述本发明的实施方式，其中相同的部件用相同的附图标记表示。在本文中，所谓近端指先进入骨头的一端，相对的一端称为远端。所谓顶端指先进入骨头的一端，相对的一端称为尾端。
如图1-2所示，本发明的组合支架包括：骨头支撑件1、近端连接件2和远端连接件3，其中所谓近端指先进入骨头的一端，相对的一端称为远端。
骨头支撑件1为多孔支架，可植入股骨头缺血性坏死髓芯减压病灶清除后形成的空腔内，起到生物力学支撑和促进血管及骨组织长入的作用。
骨头支撑件1可通过3D打印技术制备，当然也可通过非3D打印技术制备(如粉末冶金、气相沉积法或烧结法等等)。本发明所述的骨头支撑件1为多孔钛合金支架，当然支架的材料也可为钽、钛钽合金、镍钛合金、纯钛、钴合金、镁合金、磷酸钙、羟基磷灰石、聚乳酸(PLA)、乳酸-羟基乙酸共聚物(PLGA)、聚乙酸内脂(PCL)、珊瑚、生物陶瓷等材料。骨头支撑件1可根据需要加工成其他任意形体。
在一个实施例中，如图1-2所示，骨头支撑件1为多孔结构，近端连接件2为实心的或小孔结构，远端连接件3为实心的非多孔结构。这三部分共同构成支架的主体，其内部均具有贯通的孔道12。支架的骨头支撑件1图示为圆柱形，直径为5-18mm，骨头支撑件1的顶部呈半球形或弧形，以更好的维持支架顶端的力学支撑作用。半球形的弧度可根据需要进行调整。
可选地，骨头支撑件1的整体长度为40-200mm，骨头支撑件1的孔的柱宽为100－1000um(中值为300um)、孔径为100－3000um(中值1000um)，并且骨头支撑件1的孔隙率为40-90％。
支架组配完成后，孔道12贯穿于整个支架。孔道12在组配的支架内部纵行，孔道12的直径为1-8mm。
可选地，孔道12的数量为两个，两个孔道在远端连接件3的尾端穿出，在骨头支撑件1的顶部相互连通。可实现血管的植入：通过将血管(如大/小隐静脉、邻近的或其他部位的小动静脉束、人工血管或者人工血管结合自体血管等等)移植入支架内相互连通的两个孔道内，并与髋关节周围现存的血供系统(如旋股外侧动静脉系统等)吻合，实现支架的血管化，以促进支架及病变区域内的血管生长，实现病变区域微循环系统的重建，为新生骨组织提供所需的干细胞、氧气、营养物质、生长因子及清除局部的代谢废物。支架植入血管束后可直接使用，也可在多孔结构内部加载生长因子(如BMP-2/VEGF等)或干细胞等从而进一步加强其促进骨再生的能力。
可选地，在骨头支撑件1的顶端或顶部的侧方具有凹陷，形成开窗，两个孔道12在该凹陷中连通。该开窗能够供血管植入和避免血管的卡压。开窗可以位于骨头支撑件1的顶部的一侧或顶端，开窗的大小、形状和位置可根据需要进行调整。另外，骨头支撑件1的顶部亦可为全覆盖的多孔结构(无窗口)。
可选地，如图5所示，在一个实施例中，开窗位于骨头支撑件1的顶部的侧面。侧方开窗的范围可上下有所浮动，在开窗的内侧，在骨头支撑件1内，两个孔道12之间可以伴有或不伴有中隔。
可选地，如图6-8所示，在一个实施例中，远端连接件3的尾部的外围设计有螺纹区13，螺纹的长度：4-50mm，螺纹区内部的支架部分为非多孔结构(带两血管通道的实心结构)。
另外，远端连接件3的尾端底部设计有凹槽14，以便与外部连接器连接以实现支架的拧入。凹槽14也可以位于远端连接件3尾部的侧面。
可选地，如图7所示，在一个实施例中，远端连接件3的尾端底部设计有凹孔15，以便与外部连接器连接以实现支架的拧入。凹孔15也可以位于远端连接件3尾部的侧面。
可选地，如图8所示，在一个实施例中，远端连接件3的尾端底部设计有凸起结构16，以便与外部连接器连接以实现支架的拧入。凸起结构16也可以位于远端连接件3尾部的侧面。
可选地，如图9所示，在一个实施例中，可以给图3-5所示的开窗配盖17。
本发明的组合支架的近端连接件2结合在骨头支撑件1的远端，近端连接件2与骨头支撑件1为一体化结构。近端连接件2带有外置的连接螺纹结构18，其直径小于股骨支撑件1的直径。近端连接件2根据骨头支撑件1的远端形状可以变化。远端连接件3的直径与骨头支撑件1的直径一致，远端连接件3的近端带有内置的连接螺纹结构19，可与近端连接件2的外置的连接螺纹结构相互拧入而实现支架的匹配组合，组合完成后，其内部的孔道可实现完全对接和相互贯通。
如图1所示，近端连接件2内部有孔道，用于与骨头支撑件1的孔道对接。
在图1所示的实施例中，组合支架的近端连接件2结合在骨头支撑件1的远端，近端连接件2与骨头支撑件1为一体化结构。近端连接件2带有外置的连接螺纹结构18，其直径小于股骨支撑件1的直径。近端连接件2根据骨头支撑件1的远端形状可以变化。远端连接件3的直径与骨头支撑件1的直径一致，远端连接件3的近端带有内置的连接螺纹结构19，可与近端连接件2的外置的连接螺纹结构相互拧入而实现支架的匹配组合，组合完成后，其内部的孔道可实现完全对接和相互贯通。
对应于如图6-8所示完成组合后，支架的尾端(即远端连接件3的尾端)具有凹槽14、凹孔15或凸起16结构，用于支架与外部连接器的连接，以实现支架的拧入。凹槽、凹孔及凸起的形状、大小、位置等可根据需要进行相应的调整和变化。
可选地，骨头支撑件1和近端连接件2为一体式结构，其中近端连接件2为实心的，也可以为小孔结构。
在一个实施例中，骨头支撑件1直径为5-18mm，长度5-50mm。近端连接件2的长度为5-50mm，骨头支撑件1和近端连接件2为一体化结构，其总长度为20-100mm。远端连接件3的长度为20-150mm。
使用时，支架植入股骨头坏死髓芯减压病灶清除后的骨隧道后，近端连接件2的尾端位置高于正常髋关节置换术中股骨颈截骨线的位置，即植入后连接区位于股骨颈的近端和/或中段。
本发明的组合支架的优点：若后期出现股骨头坏死塌陷，需要行关节置换手术时，由于近端的多孔部分(骨头支撑件1)有骨长入，远端部分为实心结构(远端连接件3)没有骨长入，可将远端部分拧出，再于股骨颈部截断股骨颈，而截骨区不再有支架的干扰，因此不会干扰髋关节置换术的正常进行。
以上所述的实施例，只是本发明较优选的具体实施方式，本领域的技术人员在本发明技术方案范围内进行的通常变化和替换都应包含在本发明的保护范围内。

Claims (10)

1.一种组合支架，其特征在于，包括：
骨头支撑件(1)，骨头支撑件(1)内具有孔道(12)；
近端连接件(2)，近端连接件(2)连接骨头支撑件(1)尾部，近端连接件(2)内具有孔道(12)；和
远端连接件(3)，远端连接件(3)连接在近端连接件(2)尾部，远端连接件(3)内具有孔道(12)，
骨头支撑件(1)、近端连接件(2)和远端连接件(3)构成支架连接后，其内部的孔道(12)相互贯通。
2.根据权利要求1所述的组合支架，其特征在于，
孔道(12)的数量为至少两个，孔道(12)在远端连接件(3)的底部穿出，在骨头支撑件(1)的顶部或侧部相互连通。
3.根据权利要求2所述的组合支架，其特征在于，
骨头支撑件(1)的顶端或顶部的侧方具有凹陷以形成开窗，孔道(12)在该凹陷中连通。
4.根据权利要求3所述的组合支架，其特征在于，
所述开窗配有用于遮盖所述开窗的盖(17)。
5.根据权利要求2所述的组合支架，其特征在于，
孔道(12)之间伴有中隔。
6.根据权利要求1所述的组合支架，其特征在于，
远端连接件(3)的尾部的底端或侧面具有凹槽(14)、凹孔(15)或凸起结构(16)。
7.根据权利要求6所述的组合支架，其特征在于，
近端连接件(2)与骨头支撑件(1)为一体化结构。
8.根据权利要求6所述的组合支架，其特征在于，
远端连接件(3)的尾部外围具有螺纹区(13)，凹槽(14)、凹孔(15)或凸起结构(16)位于所述螺纹区(13)内。
9.根据权利要求8所述的组合支架，其特征在于，
近端连接件(2)具有用于连接的螺纹结构(18)，远端连接件(3)的近端具有用于连接的螺纹结构(19)，近端连接件(2)与远端连接件(3)通过连接螺纹结构(18、19)相互拧入而实现匹配组合。
10.根据权利要求1所述的组合支架，其特征在于，
骨头支撑件(1)为多孔结构，近端连接件(2)为实心的或小孔结构，远端连接件(3)为实心的非多孔结构。
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